IMPORTANT SAFETY INFORMATION

OLUX-E® (clobetasol propionate) Foam, 0.05% has been shown to reversibly suppress the hypothalamic-pituitary-adrenal (HPA) axis with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. Evaluate patients periodically for evidence of HPA axis suppression.

Cushing's Syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of OLUX-E Foam for longer than 2 weeks may suppress the immune system.

Factors that predispose a patient using a topical corticosteroid to increased total systemic corticosteroid exposure and HPA axis suppression include the use of more potent steroids, use of more than one corticosteroid-containing product at the same time, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

The pooled incidence of local adverse reactions in trials for atopic dermatitis and psoriasis with OLUX-E Foam was 1.9% for application site atrophy and 1.6% for application site reaction.

OLUX-E Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Caution should be exercised when OLUX-E Foam is administered to a nursing woman. If used during lactation, OLUX-E Foam should not be applied to the chest to avoid accidental ingestion by the infant.

The propellant in this foam is flammable; patients should avoid fire, flame, and/or smoking during and immediately following application.

OLUX-E Foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged 12 years and older.